PPI-guided Postoperative Pain Therapy in the OR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Opioid Consumption
研究概览
简要总结
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
详细描述
Abstract
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery. Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.
Background
The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded study design (participants, evaluator)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) physical status I-II
- •able to read and understand the information sheet and to sign the consent form
- •being scheduled for elective ENT surgery under general anesthesia
- •age≥18 years
排除标准
- •ASA physical status of III and above
- •previous history of either drug or alcohol abuse
- •difficulty to understand pain scoring system
- •chronic users of analgesics or had used opioids within 12 h before surgery
- •implanted electronic medical devices
- •ophthalmologic diseases
- •rapid sequence induction (RSI)
- •psychiatric or mental disorders
- •surgical procedure warranting elective postoperative ventilation
结局指标
主要结局
Opioid Consumption
时间窗: first 2 postoperative hours
cumulative opioid consumption within first 2 postoperative hours
次要结局
- Postoperative Pain(first 2 postoperative hours)
研究者
Marita Windpassinger M.D.
Principal Investigator
Medical University of Vienna
